Aptus Announces Positive Initial Data from ANCHOR Post-Market Registry
ANCHOR data support prophylactic use of Heli-FX in the real world setting, especially in challenging anatomies
Late-breaking data presented at Vascular InterVentional Advances (VIVA) 2013 conference in Las Vegas
Sunnyvale, CA, October 8, 2013 – Aptus Endosystems, Inc., a medical device company pioneering solutions to enhance aneurysm repair, today announced positive initial results from its ANCHOR post-market registry evaluating the use of the Heli-FX™ EndoAnchor System in endovascular aneurysm repair (EVAR). Heli-FX is a mechanical fastening device that connects the endograft to the aorta and is designed to enhance the long-term durability of the procedure and reduce the risk of repeat interventions in EVAR. These early results from the first 250 patients demonstrate the safety and acute technical success of utilizing Heli-FX in primary and revision EVAR procedures. These data were presented for the first time by James Joye, DO, interventional cardiologist at El Camino Hospital, at the 11th VIVA conference held in Las Vegas, Nevada on October 8–11, 2013.
ANCHOR (Aneurysm Treatment Using the Heli-FX™ Aortic Securement System Global Registry), a global, multicenter, prospective post-market registry, evaluates the use of the Heli-FX system in EVAR and captures critical data on the use of the technology as well as acute and long-term procedural outcomes. Initial results from the registry showed:
· Acute safety and efficacy results with Heli-FX;
· Heli-FX is used in conjunction with a variety of endografts and in both primary and revision EVAR procedures, with primary prophylactic use outweighing revision cases by approximately three to one;
· Heli-FX was used in revision procedures to repair Type 1 endoleaks or endograft migration in patients with previously placed endografts with 91% acute technical success.
“The ANCHOR registry has been enrolling fast thanks to strong support from our physicians, and we are pleased to share these initial, early results,” said James Reinstein, president and CEO of Aptus Endosystems, Inc. “Especially interesting has been the high percentage of patients who have received Heli-FX prophylactically, showing that in the real world setting, physicians are concerned with the long term results of patients who have difficult proximal neck anatomy.”
About the Heli-FX EndoAnchor System
The Heli-FX EndoAnchor System is a mechanical fastening device that is designed to enhance the long-term durability and reduce the risk of repeat interventions in EVAR. By deploying small helical screws to connect the graft to the aorta, Heli-FX seeks to provide a permanent seal and fixation, similar to the stability achieved in an open surgical anastomosis. The Heli-FX system can be used during primary EVAR procedures to enhance an endograft’s inherent fixation and sealing mechanisms. It can also be used to repair endovascular grafts that have developed endoleaks, migrated away from the implant site, or are at risk of developing these complications, which are often seen after EVAR.
For more information, please visit www.aptusendosystems.com.